Changes to USP <1788> Subvisible Particulate Matter

DATE:  May 27, 2021

TIME:  10:00am PDT

A revised version of the USP chapter on Subvisible Particulate Matter USP<1788> became official on 1^st May 2021. USP<1788> is meant to expand on the information given in the chapters <787>, <788> and <789> to include for the first time the use of Flow Imaging techniques to provide orthogonal complimentary information to the HIAC high accuracy particle counter used in the compendial Light Obscuration Limit Test. Users are encouraged to develop a particle sizing and counting strategy using an integrated approach of orthogonal, complimentary scientific methods in order to forensically characterise and possibly identify the particle population in injectable dosage form drug products. This paper gives an overview of this amended chapter and the main new recommendations it contains.

Learning Objectives:

• Learn about the holistic approach to particle sizing and characterisation recommended by the new USP<1788> chapter right from drug discovery, through process development and on to final product quality control in the GMP manufacturing environment.
• Understand the difference between the compendial HIAC pass/fail test and complimentary orthogonal testing methods for particle characterisation.
• Understand why HIAC was chosen in the first instance to supersede the traditional microscopy method and why it remains the preferred instrument for compendial pass/fail Limit testing.

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